PsychologicalNCT03162575
Mindfulness-Based Cognitive Therapy for Fatigue in Inflammatory Bowel Disease Patients: a Randomized Controlled Trial
A study testing Mindfulness-Based Cognitive Therapy in people with Psychological, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The current study aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) for reducing fatigue in Inflammatory Bowel Disease patients in remission. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Psychological
- What is being tested?
- Mindfulness-Based Cognitive Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jul 2017to 9 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with either Crohn's disease or Ulcerative Colitis
- Currently in remission
- No expectation of a surgery in the upcoming three months
- Score on the subscale 'subjective fatigue' of the CIS (8 items) ≥ 35 (i.e. indicating severe fatigue)
- Age ≥ 18 and ≤ 75 years at the time of study entrance
- Being able to attend eight weekly group sessions of 2.5 hours in the hospital
- Being able to read, write, and speak Dutch.
- Written informed consent
Who cannot join
- Severe cognitive, neurological or psychiatric co-morbidity that could interfere with patients' participation and/or warrant other treatment, including acute suicidal ideations or behavior, diagnosis of schizophrenia or history of psychotic complaints, bipolar disorder, severe personality disorder, or history of clinically significant drug abuse or substance dependence
- Pregnancy
- Anemia (i.e. Hb < 7.4 for women, < 8.1 for men)
- Change in IBD medication (i.e. use of steroids) within 1 month before study entry
- Currently receiving psychological treatment for fatigue or for psychological/psychiatric problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Possible Beneficial Effects of Mindfulness-Based Cognitive Therapy (MBCT) in Fatigued Adult Patients With Inflammatory Bowel Disease (IBD)
The current study aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) for reducing fatigue in Inflammatory Bowel Disease patients in remission.
Read the detailed description
Fatigue is highly prevalent in patients with inflammatory bowel disease (IBD, i.e. Crohn's disease and ulcerative colitis), and may negatively impact patients' illness management, treatment adherence, and quality of life. Given this burden, effective treatment for reducing fatigue in IBD patients is warranted. A promising psychological treatment is Mindfulness-Based Cognitive Therapy (MBCT). MBCT is a standardized, highly structured eight-week group program for reducing stress, depression, fatigue and/or pain. Several meta-analyses have demonstrated the effectiveness of MBCT in reducing psychological complaints and improving quality of life. Moreover, in patients with cancer or chronic fatigue syndrome, there is preliminary evidence that MBCT can be effective in reducing fatigue. Given this lack of evidence for the efficacy of MBCT in reducing fatigue in general and the specific and strongly illness-related nature of fatigue in patients with IBD and characteristics of the illness, including its lifelong and relapsing nature, there is a need to verify whether MBCT is effective in reducing fatigue in IBD patients with severe fatigue.
This randomized controlled trial (RCT) aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) in reducing fatigue in severely fatigued IBD patients. Additionally, the effects of MBCT on clinically relevant secondary outcomes will be examined: fatigue interference, mood, IBD-specific quality of life, sleep quality, labor participation. Also patients' satisfaction will be assessed. Moreover, mediators and moderators will be examined to increase the understanding of why and for whom MBCT is particularly effective.
A randomized controlled trial will be performed, including two conditions: MBCT and a waitlist control group (who will receive MBCT after a waiting period of three months). The study sample will consist of 128 adult patients with IBD in remission and experiencing severe fatigue.
- Conditions
- Psychological
- Being tested
- Mindfulness-Based Cognitive Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Cognitive TherapyBehavioural
Also called MBCT
Structured MBCT intervention based on the protocol of Williams, Teasdale, and Segal (2002)
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | The intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2.5 hours Receives: Behavioral: Mindfulness-Based Cognitive Therapy |
| Waiting List Control | No intervention | Patients assigned to the waiting list condition will receive no intervention for three months and afterwards will receive MBCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue
Fatigue will be assessed with the Checklist Individual Strength (CIS-20)
Measured: Change from baseline in severity of fatigue symptoms at 3 months, 6 months and 12 months
Secondary outcomes (7)
Change in fatigue interference
Fatigue interference will be measured by the Fatigue Symptom Inventory (FSI)
Measured: Change from baseline in fatigue interference at 3 months, 6 months, and 12 months
Change in anxiety
Anxiety will be measured by Generalised Anxiety Disorder Assessment (GAD 7)
Measured: Change from baseline in generalized anxiety at 3 months, 6 months, and 12 months
Change in depression
Depression will be measured by Beck Depression Inventory-II (BDI-II)
Measured: Change from baseline in depression at 3 months, 6 months, and 12 months
Change in IBD-specific quality of life
IBD-specific quality of life will be measured by the IBD-Q
Measured: Change from baseline in quality of life at 3 months, 6 months, and 12 months
Change in sleep quality
Sleep quality will be measured by the Pittsburgh Sleep Quality Index
Measured: Change from baseline in sleep quality at 3 months, 6 months, and 12 months
Change in labor participation
Labor participation will be assessed with several questions
Measured: Change from baseline in labor participation at 3 months, 6 months, and 12 months
Satisfaction with treatment
Satisfaction with treatment will be assessed with several questions
Measured: Assessed at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start18 Jul 2017
- Primary completion30 May 2018
- Study completion9 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maya Schroevers, University Medical Center Groningen
- Investigators
- Maya Schroevers, PhD, Principal investigator, Department of Health SciencesGerard Dijkstra, Prof., Principal investigator, Center for Liver, Digestive and Metabolic Diseases (CLDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162575
- Sponsor's protocol ID
- 2016.316
- Status last verified
- Aug 2024
- First submitted
- 1 May 2017
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
PubMed 40243391Bredero QM, Fleer J, Smink A, Kuiken G, Potjewijd J, Laroy M, Visschedijk MC, Russel M, van der Lugt M, Meijssen MAC, van der Wouden EJ, Dijkstra G, Schroevers MJ. Long-term treatment outcomes of mindfulness-based cognitive therapy for fatigue in patients with inflammatory bowel disease: Results of a randomized controlled trial. J Psychosom Res. 2024 Dec;187:111949. doi: 10.1016/j.jpsychores.2024.111949. Epub 2024 Oct 11.
PubMed 39418854
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Beneficial Effects of Mindfulness-Based Cognitive Therapy (MBCT) in Fatigued Adult Patients With Inflammatory Bowel Disease (IBD)
- ClinicalTrials.gov ID
- NCT03162575
- Acronym / sponsor ID
- 2016.316
- Conditions
- Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 30 May 2018 (actual)
- Study completion
- 9 Nov 2019 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) for reducing fatigue in Inflammatory Bowel Disease patients in remission.
Detailed description
Fatigue is highly prevalent in patients with inflammatory bowel disease (IBD, i.e. Crohn's disease and ulcerative colitis), and may negatively impact patients' illness management, treatment adherence, and quality of life. Given this burden, effective treatment for reducing fatigue in IBD patients is warranted. A promising psychological treatment is Mindfulness-Based Cognitive Therapy (MBCT). MBCT is a standardized, highly structured eight-week group program for reducing stress, depression, fatigue and/or pain. Several meta-analyses have demonstrated the effectiveness of MBCT in reducing psychological complaints and improving quality of life. Moreover, in patients with cancer or chronic fatigue syndrome, there is preliminary evidence that MBCT can be effective in reducing fatigue. Given this lack of evidence for the efficacy of MBCT in reducing fatigue in general and the specific and strongly illness-related nature of fatigue in patients with IBD and characteristics of the illness, including its lifelong and relapsing nature, there is a need to verify whether MBCT is effective in reducing fatigue in IBD patients with severe fatigue.
This randomized controlled trial (RCT) aims to investigate the efficacy of Mindfulness-Based Cognitive Therapy (MBCT) in reducing fatigue in severely fatigued IBD patients. Additionally, the effects of MBCT on clinically relevant secondary outcomes will be examined: fatigue interference, mood, IBD-specific quality of life, sleep quality, labor participation. Also patients' satisfaction will be assessed. Moreover, mediators and moderators will be examined to increase the understanding of why and for whom MBCT is particularly effective.
A randomized controlled trial will be performed, including two conditions: MBCT and a waitlist control group (who will receive MBCT after a waiting period of three months). The study sample will consist of 128 adult patients with IBD in remission and experiencing severe fatigue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Cognitive Therapy | Experimental | Behavioral: Mindfulness-Based Cognitive TherapyThe intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2.5 hours |
| Waiting List Control | No intervention | –Patients assigned to the waiting list condition will receive no intervention for three months and afterwards will receive MBCT |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with either Crohn's disease or Ulcerative Colitis
- Currently in remission
- No expectation of a surgery in the upcoming three months
- Score on the subscale 'subjective fatigue' of the CIS (8 items) ≥ 35 (i.e. indicating severe fatigue)
- Age ≥ 18 and ≤ 75 years at the time of study entrance
Key exclusion criteria (5 listed)
- Severe cognitive, neurological or psychiatric co-morbidity that could interfere with patients' participation and/or warrant other treatment, including acute suicidal ideations or behavior, diagnosis of schizophrenia or history of psychotic complaints, bipolar disorder, severe personality disorder, or history of clinically significant drug abuse or substance dependence
- Pregnancy
- Anemia (i.e. Hb < 7.4 for women, < 8.1 for men)
- Change in IBD medication (i.e. use of steroids) within 1 month before study entry
- Currently receiving psychological treatment for fatigue or for psychological/psychiatric problems.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Cognitive TherapyAlso: MBCTStructured MBCT intervention based on the protocol of Williams, Teasdale, and Segal (2002) | Behavioural | Mindfulness-Based Cognitive Therapy |
Primary outcome
Change in fatigue
Time frame: Change from baseline in severity of fatigue symptoms at 3 months, 6 months and 12 months
Fatigue will be assessed with the Checklist Individual Strength (CIS-20)
7 secondary outcomes
Change in fatigue interference
Time frame: Change from baseline in fatigue interference at 3 months, 6 months, and 12 months
Change in anxiety
Time frame: Change from baseline in generalized anxiety at 3 months, 6 months, and 12 months
Change in depression
Time frame: Change from baseline in depression at 3 months, 6 months, and 12 months
Change in IBD-specific quality of life
Time frame: Change from baseline in quality of life at 3 months, 6 months, and 12 months
Change in sleep quality
Time frame: Change from baseline in sleep quality at 3 months, 6 months, and 12 months
Change in labor participation
Time frame: Change from baseline in labor participation at 3 months, 6 months, and 12 months
Satisfaction with treatment
Time frame: Assessed at 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Derived from this study: PubMed 40243391Tiles-Sar N, Neuser J, de Sordi D, Baltes A, Preiss JC, Moser G, Timmer A. Psychological interventions for treatment of inflammatory bowel disease. Cochrane Database Syst Rev. 2025 Apr 17;4(4):CD006913. doi: 10.1002/14651858.CD006913.pub3.
- Derived from this study: PubMed 39418854Bredero QM, Fleer J, Smink A, Kuiken G, Potjewijd J, Laroy M, Visschedijk MC, Russel M, van der Lugt M, Meijssen MAC, van der Wouden EJ, Dijkstra G, Schroevers MJ. Long-term treatment outcomes of mindfulness-based cognitive therapy for fatigue in patients with inflammatory bowel disease: Results of a randomized controlled trial. J Psychosom Res. 2024 Dec;187:111949. doi: 10.1016/j.jpsychores.2024.111949. Epub 2024 Oct 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maya Schroevers, PhD principal investigator
Department of Health Sciences
Gerard Dijkstra, Prof. principal investigator
Center for Liver, Digestive and Metabolic Diseases (CLDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Cognitive Therapy in people with Psychological, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue (time frame: Change from baseline in severity of fatigue symptoms at 3 months, 6 months and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03162575, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024; AzTrials last refreshed its copy on 29 Oct 2026.